Summary: Guidance Document - Plain Language Labelling Regulations for Prescription Drugs
Useful Resources
Related acts and regulations
From Health Canada
Date adopted: 2015/04/30
Date posted: 2020/03/23
Effective date: 2020/04/01
Overview
This document provides information for industry on how Health Canada's Health Products and Food Branch interprets and applies the 2014 Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) for prescription products and those administered or obtained through a health professional.
Who this guide is for
Prescription drug sponsors seeking clarification on the Plain Language Labelling Regulations
For assistance
Our service hours are Monday to Friday from 8 a.m. to 6 p.m. (local time) and closed statuary holidays.
Contact information:
Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
Ottawa, Ontario
K1A 0K9
Telephone: 613-948-4623
Facsimile: 613-941-1812
E-mail: hc.policy.bureau.enquiries.sc@canada.ca